rTMS to Improve Cognition in Parkinson's
TMSCogReP
rTMS as a Cognitive Rehabilitation Approach in Veterans With Parkinson's Disease
3 other identifiers
interventional
56
1 country
2
Brief Summary
The purpose of this study is to examine safety, feasibility, and the behavioral and brain effects of a non-invasive treatment, repetitive transcranial magnetic stimulation (rTMS), for Veterans with Parkinson's disease or atypical parkinsonism and mild impairments in their thinking. The hypothesis is that rTMS can improve thinking for people with Parkinson's disease or atypical parkinsonism who are experiencing mild problems with their thinking ability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2020
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2019
CompletedFirst Posted
Study publicly available on registry
February 11, 2019
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2028
April 21, 2026
April 1, 2026
7 years
January 28, 2019
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in NIH sponsored Executive Abilities: Measures and Instruments for neurobehavioral evaluation and re-search (NIH-EXAMINER) executive composite score
The NIH-EXAMINER has an established 3-factor model defined by (1) cognitive control, (2) working memory (3) fluency. A confirmatory factor analysis indicates these 3-factors load on to 1-factor: executive composite score. Seven tests in the NIH-EXAMINER will be used to compute the composite score
baseline, 8 weeks, 12 weeks
Study Arms (2)
active rTMS
EXPERIMENTALFor active rTMS, a butterfly coil and MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark) will be used. One rTMS session will consist of 40 trains of 5sec each at 110% of resting motor threshold and 15Hz will be provided at the left DLPFC.
sham rTMS
SHAM COMPARATORFor sham rTMS, the procedure will be carried out at the left DLPFC but a sham coil will be used. The MagVenture coil has an active side and a placebo side allowing a double-blind study to be conducted. The sham system looks, sounds and feels like active rTMS.
Interventions
The coil will be held tangentially to the skull at approximately 45º from the midline. One rTMS session will consist of 40 trains of 5sec each at 110% of resting motor threshold and 15Hz will be provided at the left DLPFC.
Eligibility Criteria
You may qualify if:
- Veterans who seek services at Hines VA Hospital or Jesse Brown VA Medical Center
- Diagnosis of PD or atypical parkinsonism as determined by a neurologist
- Meet criteria for having mild cognitive impairment
- Receiving stable (i.e., no changes in medication and medication dose) medication and who are expected to remain on stable medication for the duration of the RCT
- Speak and read English
- years or older
You may not qualify if:
- Dementia
- Failure to demonstrate decision making capacity
- History of deep brain stimulation surgery
- Severe depression
- Resting head tremor
- Dyskinesia that will interfere with collecting imaging data
- Has congestive heart failure
- Implanted cardiac pacemaker or defibrillator
- Cochlear implant, nerve stimulator, or intracranial metal clips
- Implanted medical pump
- Increased intracranial pressure
- History of claustrophobia
- Metal in eyes/face, shrapnel/bullet remnants in brain
- Participants at potential increased risk of seizure including those who have the following:
- history (or family history) of seizure or epilepsy
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612, United States
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra L. Kletzel, PhD BA
Edward Hines Jr. VA Hospital, Hines, IL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2019
First Posted
February 11, 2019
Study Start
April 1, 2020
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 30, 2028
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Final data sets will be made available as per Hines VA Hospital local policy for long term storage and access until enterprise-level resources become available.
- Access Criteria
- These data will be available upon request by researchers and scientists in accordance with federal guidelines and Hines local policy.
Raw and/or normalized data will be made available in the form of Excel files. MRI images will anonymized and made available through the Northwestern University Neuroimaging Data Archive (NUNDA).